Hemodialysis access port and cleaning system

Abstract

An embodiment in accordance with the present invention provides a device and method for hemodialysis including a needle access port having a housing defining a septum, wherein the septum is configured for needle access. Generally, the needle access port will have three septa for communication with valves configured to be anastomosed to a large-diameter blood vessel. The valves are in fluid communication with a flow of blood through the large-diameter blood vessel. The device also includes an elongate tube having a first and a second elongate lumen, wherein a first end of the tube is coupled to the needle access port and a second end of the tube is coupled to the valve. The device can be cleaned by injecting a cleaning fluid into a first septum of the needle access port and extracting it though the second septum of the needle access port.

What is claimed is: 
     
         1 . A device for hemodialysis access comprising:
 a needle access port having a housing defining a septum, wherein the septum is configured for needle access;   a valve having an open position and a closed position, wherein the valve is further configured to be anastomosed to a large-diameter blood vessel; and,   an elongate tube having a wall defining a first and a second elongate lumen and both the first and the second elongate lumens extending from a first end of the elongate tube to a second end of the elongate tube, wherein a first end of the tube is coupled to the needle access port and wherein a second end of the tube is coupled to the valve.   
     
     
         2 . The device for hemodialysis access of  claim 1 , wherein the housing of the needle access port comprises three septa, wherein a first needle access port septum is configured for a needle to draw blood from the large-diameter blood vessel, a second needle access port septum is configured for a second needle to return blood to the large-diameter blood vessel, and the third needle access port septum is configured for a third needle to activate the valve. 
     
     
         3 . The device for hemodialysis access of  claim 2  wherein the second lumen of the elongate tubing is configured to branch off from the first lumen of the elongate tubing such that it can be connected to the third needle access port. 
     
     
         4 . The device for hemodialysis access of  claim 1  wherein the housing of the needle access port is selected from the group consisting of one of a biocompatible polymer or titanium. 
     
     
         5 . The device for hemodialysis access of  claim 1  wherein the housing of the needle access port comprises a covering formed from silicone and configured such that a needle is insertable through the covering. 
     
     
         6 . The device for hemodialysis access of  claim 1  wherein the housing of the needle access port further defines a nozzle allowing the elongate tube to be attached and detached from the needle access port. 
     
     
         7 . The device for hemodialysis of  claim 6  wherein the elongate tube further comprises a locking mechanism positioned at the first end of the elongate tube for coupling the tube to the nozzle. 
     
     
         8 . The device for hemodialysis access of  claim 1  wherein the first lumen of the elongate tube has a larger diameter than the second lumen of the elongate tube. 
     
     
         9 . The device for hemodialysis access of  claim 1  wherein the elongate tubing comprises a biocompatible material. 
     
     
         10 . The device for hemodialysis access of  claim 2  wherein the valve further comprises a flap wherein the flap is sutured to the large-diameter vessel such that the valve is flush with a wall of the large-diameter blood vessel. 
     
     
         11 . The device for hemodialysis of  claim 10  wherein a material for the flap is selected from one of the group of Dacron and ePTFE. 
     
     
         12 . The device for hemodialysis of  claim 10  wherein the valve further comprises a bi-stable valve contained in a housing and coupled to the flap, such that when the valve is in the closed position it is flush with the wall of the large-diameter blood vessel. 
     
     
         13 . The device for hemodialysis of  claim 12  wherein, when the bi-stable valve is in the closed position, the first and second lumen of the elongate tube are in fluid communication with each other and are blocked from having fluid communication with a blood stream in the large-diameter blood vessel and wherein when the bi-stable valve is in the open position the first lumen is in fluid communication with the blood stream and the second lumen is blocked from fluid communication with the blood stream in the large-diameter blood vessel. 
     
     
         14 . The device for hemodialysis of  claim 10  wherein the bi-stable valve comprises a durable biocompatible material able to withstand frequent movement and blood flow and able to be flipped from the closed position to the open position by pulling fluid from the third needle access port septum with a needle creating a negative pressure to flip the valve to the open position. 
     
     
         15 . The bi-stable valve of  claim 10  wherein the valve further comprises a durable biocompatible material able to withstand frequent movement and blood flow and able to be flipped from the open position to the closed position by injecting fluid into the third needle access port septum with a needle creating a negative pressure to flip the valve to the closed position. 
     
     
         16 . The device of  claim 2  wherein the third needle access port septum is positioned below one selected from the group consisting of the first and the second septum and separated from the one of the first and second septum by a silicone layer. 
     
     
         17 . The device of  claim 1  wherein the valve further comprises a housing having ridges along an outer surface of the housing. 
     
     
         18 . The device of  claim 1  wherein the valve further comprises a fluted opening to direct the flow of blood. 
     
     
         19 . A method of providing hemodialysis using a hemodialysis device comprising:
 anastomosing a first valve and a second valve to a large-diameter blood vessel such that the valves are in fluid communication with a flow of blood through the large-diameter blood vessel;   coupling the first valve to a first septum of a needle access port using a first elongate tube having a first lumen and a second lumen and wherein the first lumen is attached to a first nozzle of the valve and the second lumen is attached to a second nozzle of the valve;   coupling the second valve to a second septum of the needle access port using a second elongate tube having a first lumen and a second lumen wherein the first lumen is attached to a first nozzle of the valve and the second lumen is attached to a second nozzle of the valve;   using a needle to pull fluid from a third septum of the needle access port to create a negative pressure to flip open the first and second valves;   performing hemodialysis;   using a needle to inject fluid into the third septum of the needle access port to create a pressure to push the first and second valves closed.   
     
     
         20 . The method of  claim 19  further comprising cleaning the hemodialysis device by closing the first valve and the second valve and injecting cleaning fluid through the second lumen of the first elongate tube coupled to the first valve and extracting the cleaning fluid from the second lumen of the second elongate tube coupled to the second valve.